Vaccines.

COVID-19, Patents, and Trade Secrets

By David Gindler & Jasper L. Tran

Has the worldwide distribution of COVID-19 vaccines been impacted by patent rights? David Gindler, head of IP at Milbank LA, and Jasper L. Tran, senior associate at Milbank LA, argue that the story is much more complicated — making vaccines involves much more than waiving patents, they explain.

The following article, which is adapted from the authors’ conversation with Vanderbilt Law Review podcast editor Jacob Goodman on Hot Topics in Intellectual Property Law, provides an overview of the complicated intellectual property landscape associated with COVID-19 vaccines and therapeutics.

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hand opening white plastic pvc window at home.

It’s Time for the Federal Government to Get Back to Protecting the Nation Against COVID-19

By Jennifer S. Bard

Over the past two years, the Supreme Court has shown unprecedented hostility to efforts by both state and federal government to stop the spread of what every day turns out to be an even more deadly pandemic.

These decisions are devastating, and likely signal a continued attack on government authority, but they are not a reason to give up.

The federal government can still use its vast resources to slow the spread and continued mutation of the virus, by telling people what it knows of the danger, and what it knows about how to mitigate it.

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Globe and vaccine.

COVID ‘Compromise’ on International IP Underscores Need for New Approach

By Cynthia M. Ho

The leaked compromise regarding a “waiver” of international intellectual property (IP) obligations under the TRIPS Agreement for World Trade Organization (WTO) members has met harsh criticism as a shadow of the original proposal to waive international obligations regarding patent, trade secret, and copyright obligations relating to any COVID vaccine, treatment, diagnostic, or personal protective equipment (PPE).

The compromise excludes diagnostics, treatments, and PPE. It only narrowly modifies compulsory licenses of patents covering COVID vaccines. Moreover, it imposes additional restrictions on use of compulsory licenses. But still, multinational pharmaceutical manufacturers have protested even these modest changes from the status quo, arguing that there is no IP problem that needs to be fixed.

Clearly there is a problem. It has taken 18 months since the original Indian and South African proposal to get to this limited compromise, while gross vaccine inequity between wealthy and poor countries continues. In addition, the leaked compromise between four WTO members is still being debated — and even if agreement can be reached, it needs agreement of over 100 other WTO members. We need a new approach.

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close up of hands signing contract.

Using Contracts to Lessen Inequities in Access to Medicines in Pandemics and Epidemics

By Sapna Kumar and Ana Santos Rutschman

Research funding contracts can help to safeguard against profound inequities in global allocation and distribution of lifesaving diagnostics, drugs, and vaccines.

During large transnational public health crises, global demand soars for diagnostics, drugs, and vaccines. Although some of these products can be developed within compressed timelines, global production capacity remains limited. Against a backdrop of product scarcity, wealthier countries can out-bid their lower-income counterparts and capture most of the supply during the early stages of pandemics and epidemics. This leaves the vulnerable low-income populations waiting months, or even years, for their turn.

This predictable, inequitable pattern can be held off before the next pandemic. At the research and development (R&D) stage, government funders can bind producers to equity goals through targeted contractual provisions, as we explain in a recently-published Nature Biotechnology article. We summarize our proposals in the following sections. Read More

Washington DC 09 20 2021. More than 600,000 white flags honor lives lost to COVID, on the National Mall. The art installation " In America: Remember" was created by Suzanne Brennan Firstenberg.

Depoliticizing Social Murder in the COVID-19 Pandemic

­­By Nate Holdren

Lire en français.

The present pandemic nightmare is the most recent and an especially acute manifestation of capitalist society’s tendency to kill many, regularly, a tendency that Friedrich Engels called “social murder.” Capitalism kills because destructive behaviors are, to an important extent, compulsory in this kind of society. Enough businesses must make enough money or serious social consequences follow — for them, their employees, and for government. In order for that to happen, the rest of us must continue the economic activities that are obligatory to maintain such a society.

That these activities are obligatory means capitalist societies are market dependent: market participation is not optional, but mandatory. As Beatrice Adler-Bolton has put it, in capitalism “you are entitled to the survival you can buy,” and so people generally do what they have to in order to get money. The predictable results are that some people don’t get enough money to survive; some people endure danger due to harmful working, living, and environmental conditions; some people endure lack of enough goods and services of a high enough quality to promote full human flourishing; and some people inflict the above conditions on others. The simple, brutal reality is that capitalism kills many, regularly. (The steadily building apocalypse of the climate crisis is another manifestation of the tendency to social murder, as is the very old and still ongoing killing of workers in the ordinary operations of so many workplaces.)

The tendency to social murder creates potential problems that governments must manage, since states too are subject to pressures and tendencies arising from capitalism. They find themselves facing the results of social murder, results they are expected to respond to, with their options relatively constrained by the limits placed on them by capitalism. Within that context governments often resort to a specific tactic of governance: depoliticization.

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Professional business teleworkers connecting online and working from home for their corporate company, remote working and networks concept.

Introduction to the Symposium: Build Back Better? Health, Disability, and the Future of Work Post-COVID

By Chloe Reichel, Marissa Mery, and Michael Ashley Stein

This week marks the two-year anniversary of World Health Organization Director-General Tedros Adhanom declaring COVID-19 a pandemic.

It is at this particular moment that we, in the United States, are beginning to see the sociological construction of the end of the pandemic: metrics measuring COVID-19 transmission have been radically revised to reshape perceptions of risk; masks are, once again, being shed en masse; and remote workers are being urged back to the office. “It’s time for America to get back to work and fill our great downtowns again with people,” President Joseph Biden said during his March 1, 2022 State of the Union address.

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children wearing masks.

Reconsidering Mask Mandates

By Carmel Shachar

The desire to get back to “normal” is an understandable one. And despite their prevalence for the last two years, masks don’t fit into most people’s concept of normal.

But removing mask requirements means rejecting yet another public health tool to control the pandemic and protect our health care system.

First, some context: most states haven’t had indoor mask mandates in place for many months. As of February 10th, only Washington, Oregon, California, New Mexico, Hawaii, Illinois, and Delaware had statewide indoor mask mandates. These remaining few states are now taking steps to end mask policies. Some states have narrower mask mandates that apply to schools, and are similarly moving to end such policies.

But the decision to end these mandates is not made in a vacuum. We should be thinking about what other public health initiatives and components should be in place before we lift these protections.

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Child with bandaid on arm.

Reflections on Procedural Barriers to Pediatric COVID Vaccine Access

By Fatima Khan

When news broke last week that Pfizer-BioNTech was submitting for Emergency Use Authorization (EUA) a two-dose COVID vaccine regimen for children under 5 to the U.S. Food and Drug Administration (FDA), many parents felt a glimmer of hope after a long time.

Up until a few days before, the public was expecting approval to possibly drag into summer. While the regimen would likely require a third dose, it became a possibility that children could start getting some level of protection as early as March. Finally children were acknowledged during a time when their needs have often been neglected or even ignored.

The shift in the FDA’s decision process is a critical moment to reflect on how we got here, and what we should strive for to ensure children aren’t repeatedly left behind amidst our new COVID reality.

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New York, USA, November 2021: Pfizer Covid-19 Paxlovid treatment box isolated on a white background.

How to Fairly Allocate Scarce COVID-19 Therapies

By Govind Persad, Monica Peek, and Seema Shah

Vaccines are no longer our only medical intervention for preventing severe COVID-19. Over the past few months, we have seen the arrival and wider availability of treatments such as monoclonal antibodies (mAbs), and more recently, of novel oral antiviral drugs like Paxlovid and molnupiravir.

The recent Delta and Omicron surges have made these therapies scarce. The Delta variant led the federal government to resume control over mAb supply and promulgate allocation guidelines. The Omicron variant exacerbated scarcity because only one of the currently available mAbs, sotrovimab, appears to be effective against it. While Paxlovid and molnupiravir are effective against Omicron, both will likely be in short supply for many months. Paxlovid is currently constrained by a lengthy manufacturing process. Molnupiravir — which is substantially less effective — is contraindicated for use in patients under 18 and not recommended for use during pregnancy.

To allocate COVID-19 vaccines, the CDC’s Advisory Committee on Immunization Practices, the National Academies of Sciences, Engineering and Medicine (NASEM), and the World Health Organization (WHO) identified ethical goals for prioritization, such as maximizing benefit and minimizing harm, mitigating health inequities, and reciprocity. These committees, particularly the NASEM and WHO committees, included ethics experts as well as experts in social science, biology, and medicine. Current federal guidelines for therapy allocation, in contrast, do not identify ethical objectives or involve ethics expertise.

In an open-access Viewpoint in Clinical Infectious Diseases, we identify ethical goals for the allocation of scarce therapies. We argue that the same ethical goals identified for vaccine allocation–in particular maximizing benefit, minimizing harm, and mitigating health inequities — are also relevant for therapy allocation. Because many people have now taken steps to mitigate pandemic scarcity, for instance by protecting themselves through vaccination, we argue that reciprocity is also relevant.

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